Model Number ROSA BRAIN 3.0 |
Device Problem
Unintended Collision (1429)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted. .
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Event Description
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When performing markers registration, the resident accidentally collided pointer probe in the leksell frame, resulting in shutdown.There is no known impact for the patient.
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Event Description
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When performing markers registration, the resident accidentally collided pointer probe in the leksell frame, resulting in shutdown.There is no known impact for the patient.
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Manufacturer Narrative
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It was reported that a shutdown occurred during surgery due to a collision between the pointer probe and the leksell frame.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.Analysis of data log determined that the cause of the collision is a mismanagement of the vigilance device pedal which is considered as use error.Indeed, the ifu provides the information on how to prevent collisions.
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Search Alerts/Recalls
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